Informed Consent

Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

You are invited to participate in a research study conducted by Cairns Health because you self-qualified for the program and purchased it outside of the research. Self-qualifications for the program include adults with access to an Apple, Samsung, or Google smartphone, and availability to engage in the program for about 15 minutes per day for up to 8 weeks. Potential participants with Restless Legs Syndrome, narcolepsy, sleep apnea, sleep walking, bipolar disorder, seizures, substance abuse, frailty/risk of falling, severe memory problems, shift work, and pets that must sleep in the bed do not qualify for the program at this time. 

Your participation in this research study is voluntary. You should review the information below and ask questions before deciding whether to participate. Please take as much time as you need to read the consent form. You may also decide to discuss participation with your doctor and loved ones beforehand. If you decide to participate, you will be asked to sign this form. You can screenshot this form for your records and/or request a PDF be sent via email by emailing support@cairns.ai.

Purpose

This study is to formally investigate the efficacy of our product. The program, along with the device you receive with it, is considered investigational, which means that is has not been approved by the FDA.

If you choose to participate in this study, it is important for you to know that the Sponsor of this research, Cairns Health, does not provide medical advice. You should also know that this study is not intended to diagnose, treat, or address any medical problem or condition. The study is not a substitute for medical care, as Cairns Health employees will not serve as your provider or therapist, and you should continue consulting your physician and/or healthcare provider during the study. Should you experience any medical emergency during the study, please immediately call your physician or 9-1-1. If you experience suicidal thoughts, please call the National Suicide Hotline at 9-8-8 (available 24/7), call 9-1-1, or present to your local emergency room.

Procedures

You will complete the program. This involves daily content. The device will assist with the program. Typical programming takes about 5 minutes per day. You may also be asked to give open-ended feedback in an interview with Cairns Health employees at the end of the study. This will take around 30-45 minutes. All of the questions you are asked are optional, and you can skip any questions, decline interviews, and decline recording of the interviews.

Potential risks and discomforts

There are risks, discomforts, and inconveniences associated with any study, which deserve careful thought. You should talk with Cairns Health employees if you have any questions. 

Possible risks and discomforts you could experience during this study include feeling strong emotions associated with completing questionnaires for the study or using the app or device, as well as inconvenience associated with the time related to study participation. Your participation in this study may involve risks that are currently unforeseeable due to the investigational nature of this study. However, if any new risks become known in the future you will be informed of them. 

You should also talk to your physician prior to participating if you experience medical conditions such as restless legs syndrome, narcolepsy, sleep apnea, sleep walking, bipolar disorder, seizures, substance abuse, severe memory problems, or night terrors/nightmares, as this study may not be a good fit for you and could even worsen some conditions. You should always consult with your physician before participating and ask any questions about the study to Cairns Health employees. 

Surveys/questionnaires and interviews

Some of the questions may make you feel uneasy or uncomfortable. You may find answering the questionnaires boring or repetitive. If this happens, you can take a break or skip any question you don’t want to answer. You have the right to refuse to answer particular questions, or to end your participation in the research study and/or the Cairns Health program at any time. If you experience lasting discomfort, you should contact your care provider. If you don’t have a care provider, Cairns Health may be able to assist regarding how to find a referral. You will be responsible for all costs incurred as a result of the referrals.

App or device use

There are possible risks associated with using the app or device. If you find yourself experiencing any emotions more intensely than you are comfortable with, you are free to take a break or stop using the app or device at any time. You have the right to refuse to engage in particular activities or answer particular questions, and you can end your participation at any time. If you experience lasting discomfort, you should contact your care provider. If you don’t have a care provider, you can ask Cairns Health to see if they can provide any assistance regarding how to find a referral. You will be responsible for all costs incurred as a result of the referrals.

Internet and data costs

The use of the app and device require the use of an internet source. This may require the use of your cell phone’s data if you opt not to be connected to a wireless internet source. If the costs of the internet associated with this study are not affordable, you should not participate.

Confidentiality

We will keep your records for this study confidential as far as permitted by law. However, there is a potential risk of loss of confidentiality. Additionally, if we are required to do so by law, we will disclose confidential information about you. Cairns Health staff members will access your information in order to research findings from the study. Cairns Health may publish the results of this study for others to read about, but you will not be identified in any articles by name, telephone number, email address, or any other direct personal identifier. Cairns Health may also rely on third-party service providers to help process and maintain information related to the study. In those cases, the information collected by the study is also governed by those third parties’ privacy policies, along with this consent form.

In addition, if you become a danger to yourself or others, we may have to reveal information about you to mental health professionals and/or emergency services. If you reveal knowledge or suspicion of child or elderly/dependent adult abuse or neglect, the law requires that we file a report with the appropriate government agency. We will also keep your contact information and all the information you tell us in this study as confidential as possible. 

There is a small risk that people who are not connected with this study will learn your identity or your personal information. The study team has taken precautions to reduce this risk, and the data will be stored using reasonable security practices. 

The US FDA and WCG IRB may inspect all study records including your personal information.

Potential benefits to participants and/or to society

As this is a study, the benefits are contingent upon the results. Though we have received positive feedback about the program thus far, you may not receive any direct benefit from taking part in this study. Your participation in this study may help us learn how technology impacts sleep for those who use it.

Participation and withdrawal

Your participation is voluntary. Your decision whether or not to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may withdraw your consent at any time by contacting us using the information below and discontinue participation without penalty. You are not waiving any legal claims, rights or remedies because of your participation in this study.

Alternatives to participation

Your alternative is to not participate. For more information on sleep or treatments for sleep, please contact your care provider.

Emergency care and compensation for injury

If you are injured as a direct result of research procedures, you should receive medical treatment by immediately calling your physician or 9-1-1. You or your insurance will be billed for the cost. Cairns Health does not offer to provide any monetary compensation for injury. 

Study contact information

If you have any questions, complaints or concerns about the study, please feel free to email support@cairns.ai or leave a message for us at (650) 206-9499 to get connected to a Cairns Health employee that can help.

Rights of research participant – IRB contact information

If you have questions, concerns, or complaints about your rights as a research participant or the research in general and are unable to contact Cairns Health, or if you want to talk to someone independent of Cairns Health, please contact the WCG IRB:

Telephone: 855-818-2289

E-mail: researchquestions@wcgirb.com

Consent of research participant

By selecting AGREE, I am confirming that I read the information provided above. I have been given a chance to ask questions. My questions have been answered to my satisfaction, and I agree to participate in this study. I am aware I can screenshot and/or request a copy of this form by emailing support@cairns.ai or calling (650) 206-9499. By selecting DISAGREE, I am declining participation in the research study.